尼罗替尼
医学
伊马替尼
内科学
临床终点
累积发病率
髓系白血病
肿瘤科
甲磺酸伊马替尼
不利影响
队列
临床试验
作者
Koichi Miyamura,Toshihiro Miyamoto,Mitsune Tanimoto,Kazuhito Yamamoto,Shinya Kimura,Tatsuya Kawaguchi,Itaru Matsumura,Tomoko Hata,Hisashi Tsurumi,Shigeki Saito,Masayuki Hino,Seiji Tadokoro,Kuniaki Meguro,Hideo Hyodo,Masahide Yamamoto,Kohmei Kubo,Junichi Tsukada,Midori Kondo,Makoto Aoki,Hikaru Okada,Masamitsu Yanada,Kazuma Ohyashiki,Masafumi Taniwaki
标识
DOI:10.1016/j.leukres.2016.09.009
摘要
Optimal management of patients with chronic myeloid leukemia in chronic phase with suboptimal molecular response (MR) to frontline imatinib is undefined. We report final results from SENSOR, which evaluated efficacy/safety of nilotinib in this setting. A substudy assessed whether BIM polymorphisms impacted response to nilotinib. In this single-arm, multicenter study, Japanese patients with suboptimal MR per European LeukemiaNet 2009 criteria (complete cytogenetic response, but not major MR [MMR]) after ≥18 months of frontline imatinib received nilotinib 400 mg twice daily for 24 months. MR, BCR-ABL1 mutations/variants, and BIM polymorphisms were evaluated in a central laboratory. Primary endpoint was the MMR rate at 12 months (null hypothesis of 40%). Of 45 patients (median exposure, 22.08 months), 39 completed the study and six discontinued. At 12 and 24 months, 51.1% (95% CI, 35.8%–66.3%) and 66.7% (95% CI, 51.0%–80.0%) achieved MMR, respectively. Cumulative MMR incidence by 24 months was 75.6%. Of 40 patients analyzed, 10 of 12 (83.3%) with and 17 of 28 (60.7%) without BIM polymorphisms achieved MMR at 24 months. The safety profile was manageable with dose reductions and interruptions. Nilotinib provided clinical benefit for patients with suboptimal response to imatinib, and BIM polymorphisms did not influence MMR achievement. ClinicalTrials.gov: NCT01043874.
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